A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501703-27-00

Acronym

XL092-304

Enrollment

196

Registered

2023-06-20

Start date

2023-07-05

Completion date

Unknown

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Brief summary

Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC), Objective response rate (ORR) as assessed by BIRC per RECIST 1.1

Detailed description

Duration of Overall Survival (OS)

Interventions

DRUGXL092

DRUGSunitinib AqVida 12

DRUG5 mg Hartkapseln

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGSunitinib AqVida 25 mg Hartkapseln

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC), Objective response rate (ORR) as assessed by BIRC per RECIST 1.1	—

Secondary

Measure	Time frame
Duration of Overall Survival (OS)	—

Countries

Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026